Validation of Progranulin as Biomarker in Diagnostics and Prognosis of Sepsis

Projektinformationen

Vaprosep

ID Finanzhilfevereinbarung: 672801

DOI

10.3030/672801

Projekt abgeschlossen

EK-Unterschriftsdatum 13 April 2015

Startdatum 1 Mai 2015

Enddatum 30 September 2015

Finanziert unter

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Gesamtkosten

€ 71 429,00

EU-Beitrag

€ 50 000,00

Koordiniert durch

MEDIAGNOST GESELLSCHAFT FUR FORSCHUNG UND HERSTELLUNG VON DIAGNOSTIKA GMBH
Germany

Periodic Reporting for period 1 - Vaprosep (Validation of Progranulin as Biomarker in Diagnostics and Prognosis of Sepsis)

Berichtszeitraum: 2015-05-01 bis 2015-09-30

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

Sepsis is a complex, systemic and inflammatory host reaction to an infection. With worldwide 20-30 million cases, sepsis is regarded as a hidden epidemic. Because the clinical diagnosis is unreliable, there is a strong need for a reliable biomarker. Preliminary data prove that progranulin (PGRN) allows a highly sensitive and specific detection of sepsis, a timely monitoring of the disease course and a differentiation between viral and bacterial causes of the disorder.

Objectives of the feasibility study were the evaluation of the economic potential of PGRN in sepsis diagnostics and the development of a marketing strategy to implement its measurement in clinical routine.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

Key opinion leaders in the EU were contacted and 13 experts answered the structured interview, proving the strong need for a valid sepsis biomarker. Based on their recommendations a biomarker validation study protocol was developed and potential clinical partners were recruited. Regulatory and reimbursement analysis did not reveal any obstacles regarding successful market implementation. Also the feasibility study confirmed the economic advantages of PGRN as biomarker in reduction of the length of stay in the intensive care unit (500-1000€/day) and avoidance of unnecessary antibiotic therapy (10-500€/day). Analysis of production costs revealed that a price of PGRN measurement of 10€ is reasonable. Market potential of 6.2 Mio patients in the US and EU allows to achieve the break-even point and an ROI of 54% within nine years after project start based on a conservatively estimated market share of 10%. The marketing strategy to achieve this market share includes well known tools like scientific publications, congress participation and direct customer contact. The successfully validated PGRN measurement will be introduced in third level hospitals in the EU initially, followed by market access in the US. Long term strategy involves implementation of PGRN measurement also in second level hospitals to increase market penetration and revenues. Based on a strong intellectual property strategy this market is available only for Mediagnost. After PGRN is established as biomarker in sepsis diagnostics the subsequent strategic product development includes point of care systems.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

The feasibility study proofs that Vaprosep is a clinically and economically important and realistic project, which is worth further funding to realize the ambitious goals and improve medical care and economic growth.

Receiver operating characteristic curve showing sensitivity and specificity of PGRN as a biomarker